Smart Coil 400SMTSFT3H06Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548017006), received between Sep 14, 2017 and Oct 7, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL (400SMTSFT3H06) INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE (F103332); HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL DID NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN ALSO ATTEMPTED TO DETACH THE SMART COIL USING FORCEPS BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL (400SMTSFT3H06) INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE (F103332); HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PHYSICIAN THEN PLACED THREE NON-PENUMBRA COILS AND FOUR SMART COILS INTO THE TARGET LOCATION USING A NEW HANDLE (F96975). NEXT, THE PHYSICIAN ADVANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595122 ↗
• MalfunctionOct 7, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA SMART COILS (SMART COILS), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND TWO SMART COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER SMART COIL (400SMTSFT3H06) INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE (F103332); HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, BUT THE SMART COIL DID NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN ALSO ATTEMPTED TO DETACH THE SMART COIL USING FORCEPS BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL (400SMTSFT3H06) INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE (F103332); HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE SMART COIL WAS ALSO REMOVED. THE PHYSICIAN THEN PLACED THREE NON-PENUMBRA COILS AND FOUR SMART COILS INTO THE TARGET LOCATION USING A NEW HANDLE (F96975). NEXT, THE PHYSICIAN ADVANCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595118 ↗
• MalfunctionApr 1, 2021Unraveled Material; Difficult or Delayed Separation; Unraveled Material; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA CATHETER, NON-PENUMBRA MICROCATHETER, GUIDEWIRE, AND A NON-PENUMBRA STENT. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL AS THE FIRST COIL INTO THE VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE SMART COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS. THE PHYSICIAN THEN BROKE THE BLACK ALIGNMENT ZONE ON THE PUSHER ASSEMBLY OF THE SMART COIL AND PULLED THE INNER WIRE IN ATTEMPT TO MANUALLY DETACH THE SMART COIL. HOWEVER, THE COIL DID NOT DETACH. CONSEQUENTLY, DURING THE ATTEMPTS, THE SMART COIL BECAME UNRAVELED. THEREFORE, THE PHYSICIAN USED A GOOSE NECK SNARE TO RETRIEVE THE SMART COIL AND REMOVED THE MICROCATHETER ALL TOGETHER. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11604025 ↗
• MalfunctionDec 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL), NON-PENUMBRA COILS, AND TWO NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE NON-PENUMBRA COILS INTO THE TARGET VESSEL USING A MICROCATHETER. THEN, THE PHYSICIAN PLACED SUCCESSFULLY A SMART COIL INTO THE TARGET VESSEL USING A MICROCATHETER. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING THE PUSHER ASSEMBLY OF THE SMART COIL THROUGH THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN FELT AS IF THE SMART COIL UNRAVELED; HOWEVER, NO DAMAGE TO THE SMART COIL WAS NOTED VIA FLUOROSCOPY. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10955131 ↗
• MalfunctionApr 17, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PENUMBRA SMART COIL (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SMART COIL INTO THE ANEURYSM USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN MADE SEVERAL ADDITIONAL ATTEMPTS; HOWEVER, THE SMART COIL DID NOT DETACH. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL; HOWEVER, THE SMART COIL DID NOT DETACH. IT WAS REPORTED THAT WHILE THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL, THE MICROCATHETER SHIFTED OUT FROM THE TARGET LOCATION; THEREFORE, THE MICROCATHETER AND THE SMART COIL WERE REMOVED TOGETHER FROM THE PATIENT. AFTER THE REMOVAL, THE PHYSICIAN NOTICED THAT THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9972800 ↗
• MalfunctionJan 17, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE, BUT THE HANDLE WAS UNABLE TO DETACH THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. THE PHYSICIAN THEN RE-ADVANCED THE SMART COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT AGAIN USING THE HANDLE, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE SMART COIL WAS REMOVED AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOUR OTHER SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9602968 ↗
• MalfunctionMay 23, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND TWO PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLES). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ADVANCED AND ATTEMPTED TO DETACH A SMART COIL IN THE TARGET LOCATION, HOWEVER THE SMART COIL DID NOT DETACH, DESPITE THREE ATTEMPTS WITH THE HANDLE. THE PHYSICIAN, THEREFORE, ATTEMPTED TO DETACH THE SMART COIL USING A NEW HANDLE, HOWEVER THE SMART COIL STILL DID NOT DETACH. THE SMART COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING TWO OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7538792 ↗
• MalfunctionJan 18, 2018Looping; Failure to Advance; Physical Resistance; Looping; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN TESTED THE SMART COIL IN A TRAY OF SALINE BEFORE ATTEMPTING TO ADVANCE IT INTO THE HUB OF THE NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE AFTER THE SMART COIL FORMED A LOOP WHILE ADVANCING OUT OF THE TIP OF THE INTRODUCER SHEATH AND INTO THE HUB OF THE NON-PENUMBRA MICROCATHETER, AND THEREFORE THE SMART COIL WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW SMART COIL AND ADDITIONAL COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7204440 ↗
• MalfunctionSep 14, 2017Fracture; Difficult or Delayed Activation; Fracture; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY-POSTERIOR COMMUNICATING ARTERY (IC-PC) USING PENUMBRA SMART COILS AND PENUMBRA SMART COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA MICROCATHETER THROUGH A NON-PENUMBRA GUIDE CATHETER, TOWARDS THE RIGHT IC-PC AND THEN DEPLOYED AND DETACHED THREE SMART COILS INTO THE TARGET VESSEL USING A HANDLE. THE PHYSICIAN THEN HAD DIFFICULTY DETACHING THE FOURTH SMART COIL (LOT # F73015) USING THE HANDLE. AFTER SEVERAL ATTEMPTS, THE COIL SUCCESSFULLY DETACHED. WHILE ATTEMPTING TO ADVANCE THE FIFTH SMART COIL (LOT #F70649), THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE FOURTH COIL''S DISTAL DETACHMENT TIP (DDT) WAS FRACTURED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A GUIDEWIRE TO PUSH THE DDT INTO THE ANEURYSM. THE PHYSICIAN RE-ADVANCED THE FIFTH SMART COIL THROUGH THE MICROCATHETER AND ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN OPENED A NEW HANDLE AND THE COIL WAS DETACHED WITHOUT ISSUE. WHILE ATTEMPTING TO ADVANCE THE NINTH SMART COIL (LOT # F70768) THROUGH THE MIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6866992 ↗